BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFREEZE CRYOSPRAY ABLATION SYSTEM

    MDR report key: 3642068 · Received February 7, 2014

    Report

    Report Number
    3010140265-2014-00001
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    December 6, 2013
    Report Date
    January 8, 2014
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K113021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO CSA MEDICAL BECAUSE AN EVALUATION WAS NOT NECESSARY, AS THE DEVICE DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, SPRAY CRYOTHERAPY PERFORMED ON DISTAL AND PROXIMAL ESOPHAGEAL TUMORS OF(B)(6) YEAR OLD FEMALE PATIENT. PATIENT WAS ON VARIOUS MEDICATIONS DUE TO MEDICAL HISTORY, INCLUDING ASPIRIN, WHICH WAS NOT STOPPED FOR THIS PROCEDURE. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO OUTSIDE HOSPITAL FOR HEMATEMESIS X 1, REPEATED ONCE WHILE IN THE EMERGENCY ROOM. HER OTHER COMPLAINT WAS CHRONIC DYSPHAGIA. WHILE UNDER EVALUATION SHE HAD ANOTHER EPISODE OF EXPRESSIVE APHASIA. SHE RECEIVED INTRAVENOUS PANTOPRAZOLE AND CESSATION OF ASPIRIN THERAPY. HEMOGLOBIN 8.9. ON (B)(6) 2013, SHE WAS TRANSFERRED TO THE (B)(6). ADMISSION HEMOGLOBIN WAS 8.6. ON (B)(6) 2013, THE HEMOGLOBIN WAS NOTED TO BE 7.5 WITHOUT EVIDENCE OF GI BLEEDING. ON (B)(6) 2013, SHE RECEIVED A TRANSFUSION, WITH A HEMOGLOBIN RISE TO 11.1. ON (B)(6) 2013, AN EGD WAS PERFORMED, WHICH SHOWED A MEDIUM-SIZED, PARTIALLY OBSTRUCTING, FUNGATING MASS IN THE DISTAL ESOPHAGUS. NO ACTIVE BLEEDING WAS SEEN. BECAUSE OF ONGOING DYSPHAGIA AND THE OBSTRUCTING NATURE OF THE LESION, REPEAT LIQUID NITROGEN CRYOTHERAPY USING THE TRUFREEZE SYSTEM WAS PERFORMED USING STANDARD TECHNIQUE. THE PROXIMAL TUMOR WAS TREATED WITH 3 X 20 SECOND SPRAY, DISTAL TUMOR WITH 2 X 20 SECOND SPRAY. THERE WERE NO IMMEDIATE COMPLICATIONS, AND ESTIMATED BLOOD LOSS WAS MINIMAL. ON (B)(6) 2013, PATIENT EXPERIENCE NO FURTHER BLEEDING, AND WAS DISCHARGED. FOLLOW-UP TELEPHONE DISCUSSION WITH THE PATIENT'S DAUGHTER ON (B)(6) 2014, INDICATED NO FURTHER EVIDENCE OF GI BLEEDING. ASSESSMENT: THE CAUSE OF THIS PATIENT'S UPPER GASTROINTESTINAL BLEED WAS HER ESOPHAGEAL CARCINOMA. THIS TUMOR EXHIBITED CONTACT BLEEDING PRIOR TO THERAPY, AND THE PATIENT WAS MAINTAINED ON ASPIRIN 325 MG AND PREDNISONE 2.5 MG DAILY FOR CORONARY ARTERY DISEASE AND POLYMYALGIA RHEUMATIC, RESPECTIVELY. BLEEDING OCCURRED 15 DAYS AFTER LIQUID NITROGEN SPRAY CRYOTHERAPY. THEREFORE, BLEEDING WAS FELT TO BE POSSIBLY DUE TO CRYOTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80920 TRUFREEZE CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R