BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 7037526 · Received November 16, 2017

    Report

    Report Number
    3008780134-2017-00019
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    July 8, 2017
    Report Date
    October 20, 2017
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER OR NOT THE ULCER AND SUBSEQUENT BLEED OCCURRED AT THE ABLATION SITE OR ELSEWHERE IN THE ESOPHAGUS. OUT OF AN ABUNDANCE OF CAUTION IT WILL BE ASSUMED THAT THE ULCER WAS NEAR TO OR AT THE ABLATION SITE. THEREFORE, THE BLEEDING IS LIKELY PROCEDURE-RELATED. NO DEVICE MALFUNCTION WAS REPORTED AND THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    C2 BECAME AWARE OF GI BLEED EVENT ON (B)(6) 2017 WITH A (B)(6) MALE COMMERCIAL PATIENT. PRIOR CRYOBALLOON PROCEDURES ON (B)(6) 2017 AT THE COMPLAINANT SITE. GI BLEEDING OCCURRED ON (B)(6) 2017. ENDOSCOPY WAS PERFORMED AND AN ULCER IN THE ESOPHAGUS WAS FOUND AT A DIFFERENT HOSPITAL (NOT COMPLAINANT SITE). ON (B)(6) 2017 PATIENT WAS TREATED AT COMPLAINANT SITE WITH CRYOBALLOON AND NO ISSUES WERE OBSERVED. NO VISIBLE ULCER WAS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817213 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS, INC. FG 1012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other