BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 6250635 · Received January 13, 2017

    Report

    Report Number
    3008780134-2016-00021
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 14, 2016
    Report Date
    January 13, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROLLER DATA WAS DOWNLOADED AND REVIEWED. DATA SHOWS 22 ABLATIONS PERFORMED, CONFIRMING THE REPORT. THERE WERE 5 HIGH BALLOON PRESSURE ERRORS (PRESSURES PEAKED AT 4.5 PSIG, AND THE SOFTWARE AUTOMATICALLY PREVENTED PRESSURE FROM INCREASING) AND ONE AUTO TURN OFF ERROR (NORMAL AT THE END OF A PROCEDURE). THE TREATMENT TIMES WERE THE CORRECT LENGTH, E.G., THE TREATMENTS SET TO 10-SECONDS ARE 10-SECONDS LONG AND THE TREATMENTS SET TO 5-SECONDS ARE 5-SECONDS LONG. THE CATHETER WAS INSPECTED, AND A KINK IN THE CATHETER SHAFT WAS NOTED. THIS KINK MAY BE RELATED TO THE HIGH BALLOON PRESSURE ERRORS. THE ANALYSIS SHOWED THAT THE DEVICE OPERATED WITHIN SPECIFICATION, AND THERE WAS NO EVIDENCE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A CRYOABLATION PROCEDURE OF 22 ABLATION SITES AND SUBSEQUENTLY REPORTED A 101 DEGREE TEMPERATURE. THE DOCTOR PERFORMED A CT SCAN, AND THE PATIENT WAS NEGATIVE FOR PERFORATION. THE PATIENT WAS DIAGNOSED WITH TRANSMURAL INFLAMMATION (PLEURAL EFFUSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33312 C2 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG--1009, FG-1012 09162016-01 , 11092016-01

    Patients

    Seq Age Sex Outcome Treatment
    1