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Terminated

C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

FDA Recall Z-1477-2017 · Posted 2017-03-15

Recalling FirmC2 Therapeutics, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2017-01-06
Date Terminated2017-09-13
Product Quantity755 controller caps

Reason for Recall

The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

Firm Action

Firm initially notified consignees who would be using the device in an upcoming procedure on January 6, 2017 to alert them of the potential issue and recommended that products with the affected cap not be used unless it can be checked by a C2 rep. Controller caps will be replaced within a few weeks; facilities will receive replacement caps by mail along with a shipping inventory label for return of those currently on hand. Formal recall letters were sent on January 19, 2017. Letters were sent by e-mail with receipt and read confirmation and follow up by phone call.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017-01-05K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016-04-13K131523CRYOBALLOON FOCAL ABLATION SYSTEMC2 Therapeutics · 2013-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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