BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6190364 · Received December 20, 2016

    Report

    Report Number
    3008780134-2016-00020
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 16, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    UDI-DI
    00854924006125
    PMA / PMN Number
    K152329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS NOT RETURNED. THE DATA FROM THE RETURNED CONTROLLER WAS DOWNLOADED AND ANALYZED. DURING THE PROCEDURE, 6 COMPLETE, 10-SECOND ABLATIONS WERE PERFORMED. THERE WERE 6 ERRORS FOR HIGH BALLOON PRESSURE (4.5 PSIG), CONFIRMING THE COMPLAINT. THE RETURNED CONTROLLER WAS TESTED UNDER SIMULATED USE CONDITIONS. FOUR COMPLETE ABLATIONS WERE SUCCESSFULLY PERFORMED WITH NO DEVICE FUNCTIONALITY ISSUES. THE ERROR REPORTED WAS NOT REPLICATED, AND THE ROOT CAUSE IS INCONCLUSIVE. AS DETERMINED BY THE PHYSICIAN, THE PATIENT'S DIFFICULTY SWALLOWING IS UNRELATED TO THE DEVICE.

    Description of Event or Problem · 1

    DURING THE ABLATION PROCEDURE ON (B)(6) 2016, 6 ABLATIONS OF 10 SECONDS EACH WERE COMPLETED SUCCESSFULLY. ON ABLATION 7, THE BALLOON DEFLATED PREMATURELY AFTER 2 TO 3 SECONDS (2 ATTEMPTS). THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2016 DURING TELEPHONE FOLLOW-UP, THE PATIENT REPORTED DIFFICULTY SWALLOWING. THE PATIENT WAS NOT HOSPITALIZED, BUT HIS MEDICATION AND DIET WERE CHANGED. ON (B)(6) 2016, THE PATIENT WAS ABLE TO EAT SOFT FOOD BUT WAS STILL HAVING DIFFICULTY SWALLOWING. THE PHYSICIAN DETERMINED THAT THIS ADVERSE EVENT IS MILD IN ITS INTENSITY AND IS PROCEDURE RELATED, NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839521 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG-1012, FG-1009 09222016-01 00854924006125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention