C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device

FDA device recall Z-1477-2017 · posted 2017-03-15 · Terminated

Recall details

Recalling firm

C2 Therapeutics, Inc.

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.

Action taken

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

Status

Terminated

Product code

GEH

Quantity affected

755 controller caps

Distribution

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

Date initiated

2017-01-06

Date posted

2017-03-15

Date terminated

2017-09-13

Location

Redwood City, CA

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